Heys S D, Eremin O, Ruggeri E M, Pein F, Rainer H, Oskam R, de Peuter R A, Palmer P A, Franks C R
University Department of Surgery, Aberdeen, U.K.
Eur J Cancer. 1995;31A(1):19-25. doi: 10.1016/0959-8049(94)00360-h.
135 patients with locally advanced or metastatic colorectal cancer were entered into a phase III trial evaluating the efficacy of chemoimmunotherapy [recombinant interleukin 2 (rIL2)/5-fluorouracil (5-FU) and leucovorin (LV)] versus chemotherapy alone (5-FU/LV). A cycle of chemoimmunotherapy comprised a constant intravenous infusion of rIL2 at a dose of 18 x 10(6) U/m2/24 h for 120 h, followed by three bolus injections of 5-FU (600 mg/m2) and LV (25 mg/m2) at weekly intervals. Patients receiving chemotherapy alone received 5-FU/LV at the same dose at weekly intervals for 6 weeks followed by a rest period of 2 weeks, constituting one cycle of therapy. A maximum of 6 months therapy was given in both arms of the study. The response rates (complete and partial responses) were 17% in patients receiving rIL2/5-FU/LV versus 16% in those in the 5-FU/LV arm of the study. Median survival and progression-free survival were comparable for the two groups of patients, although there was a trend for a prolongation of survival in patients receiving chemoimmunotherapy compared with chemotherapy alone, beyond 12 months. Retrospective subgroup analyses revealed a significantly increased survival in poor prognosis patients (ECOG 1) treated with rIL2/5-FU/LV when compared to those receiving chemotherapy alone. Therefore, further studies evaluating the dose and duration of chemoimmunotherapy in patients with metastatic colorectal cancer seem warranted.
135例局部晚期或转移性结直肠癌患者进入一项III期试验，评估化学免疫疗法[重组白细胞介素2（rIL2）/5-氟尿嘧啶（5-FU）和亚叶酸（LV）]与单纯化疗（5-FU/LV）的疗效。一个化学免疫治疗周期包括以18×10⁶U/m²/24小时的剂量持续静脉输注rIL2 120小时，随后每周间隔三次推注5-FU（600mg/m²）和LV（25mg/m²）。单纯接受化疗的患者每周间隔接受相同剂量的5-FU/LV，持续6周，随后休息2周，构成一个治疗周期。研究的两个组均给予最长6个月的治疗。接受rIL2/5-FU/LV治疗的患者的缓解率（完全缓解和部分缓解）为17%，而研究中5-FU/LV组的患者为16%。两组患者的中位生存期和无进展生存期相当，尽管与单纯化疗相比，接受化学免疫疗法的患者在12个月后有生存期延长的趋势。回顾性亚组分析显示，与单纯接受化疗的患者相比，接受rIL2/5-FU/LV治疗的预后不良患者（ECOG 1）生存期显著延长。因此，似乎有必要进一步开展研究，评估转移性结直肠癌患者化学免疫疗法的剂量和疗程。
